Jamie Rosen

In this guest post, Jamie Rosen—media and communications manager at Aeras—writes about a new film series that features personal stories of people affected by tuberculosis (TB) worldwide, and the urgent need to develop new vaccines and other tools against the disease. Aeras is excited to share the trailer for a series of short films exposing the underreported global epidemic of TB and the movement for innovation to improve our tools to fight it. In the TB community, as in other areas of global health, we are constantly seeking ways to help people comprehend the scale and the individual tragedy of this disease, to understand the difficulties of treating it, and to inspire people to do what it takes to adequately address it. Aeras has been working with filmmaker Mo Scarpelli and her crew over the past several months to produce four films. Each film will focus on the story of one individual interspersed with expert interviews, and will feature footage from five countries around the world. The first film will focus on an American multi-drug resistant TB survivor; the second on an Indian TB doctor; the third on a South African woman who volunteered for a clinical trial; and the fourth on a British researcher working to develop new TB vaccines. Aeras is grateful for the advice and participation of many people who are working tirelessly to take care of today’s TB patients and foster hope for a better future—one with more effective diagnostics, drugs and ultimately vaccines against this rapidly evolving disease. If this trailer inspires you, please go to www.aeras.org and spread the word. For more information or to organize a screening, please contact Jamie Rosen at jrosen@aeras.org.

In this guest post, Jamie Elizabeth Rosen—media & communications manager at Aeras—discusses a new effort to develop a novel tuberculosis (TB) vaccine candidate. Dr. Steven Reed is the founder, president, and chief scientific officer of the Infectious Disease Research Institute (IDRI), located in Seattle, Washington. IDRI is a 120-person nonprofit biotech committed to applying innovative science to the research and development of products to prevent, detect, and treat infectious diseases of poverty. My organization—Aeras, a nonprofit biotech focused on developing vaccines against TB—recently announced with IDRI a collaboration to conduct joint development activities with respect to IDRI’s novel TB vaccine candidate, called ID93 + GLA-SE. The collaboration was formed to accelerate the development of ID93 + GLA-SE by combining resources and expertise. IDRI’s internal development programs focus on three neglected infectious diseases—leishmaniasis, TB, and leprosy. But the organization has also collaborated or provided access to its vaccine technologies for a much wider range of infectious diseases and conditions, including malaria, pandemic influenza, HIV, hookworm, and Chagas. I asked Dr. Reed why IDRI got involved in TB. “IDRI started working on tuberculosis vaccines 20 years ago as an unmet need, and I have been working on TB since graduate school,” he said. “So we had knowledge of the disease and this question, and nobody else was addressing it.” Dr. Steven Reed, founder, president, and chief scientific officer at IDRI Although TB continues to claim the lives of more men, women, and children than any other infectious disease except HIV and AIDS, efforts to develop TB vaccines in clinical trials stalled for nearly 80 years. Part of the reason is that a vaccine against TB was invented and rolled out in 1921. But Bacille Calmette-Guerin (BCG), the most widely used vaccine in the world, has done little to stem the TB epidemic globally. While it helps prevent severe forms of TB in children, it is not very effective against adult pulmonary TB, the most common and contagious form of the disease. Only in the past decade has momentum in clinical development of new vaccines accelerated its pace. ID93 + GLA-SE is designed to boost protection afforded by BCG. It is slated to join a dozen vaccine candidates that are now undergoing clinical trials to test their safety and efficacy in protecting people from TB. Vaccine development is particularly complex for TB, so scientists are testing multiple candidates simultaneously so they can deliver new vaccines to protect the people who are most at risk for TB as soon as possible. I asked Dr. Reed why this vaccine candidate holds promise. “The main thing is that ID93 + GLA-SE is designed to boost the current vaccine, BCG. Secondly, the intellectual property for this vaccine candidate is held by IDRI and available for developing country manufacturers. Thirdly, it’s easily scaled and can be affordable. It has to be. So there’s no question in terms of making enough doses at an affordable price, which is not true for most live vaccines. Fourthly, it has a very extensive safety and efficacy data package and TB models.” The vaccine candidate contains four proteins recognized in both latent and active TB. One of every three people worldwide is already infected with latent TB, a dormant state of the disease that can reside in the body for years and will ultimately make about 10 percent of people who have it sick. The vaccine also contains the GLA adjuvant to enhance immune response. ID93 + GLA-SE has already been tested pre-clinically and, pending approval, will enter its first Phase I clinical trial in the United States this year. “We funded this program with over $35 million dollars from NIH [the National Institutes of Health] over the last 15 years,” said Dr. Reed. “All of the preclinical development is done with federal funds, with some industry support. We think working with Aeras will speed the process and integrate us a little more into the community of other vaccines that are in development.” Dr. Reed has a PhD in microbiology and immunology from the University of Montana, which served as a reference lab for BCG—the current TB vaccine—in the 1970s. He started working in global health as a Cornell University Medical College faculty member, and he worked in Brazil for five years in the 1980s. He developed the first recombinant TB vaccine to enter clinical trials, M72, which is now licensed to GlaxoSmithKline. In addition to vaccines, IDRI is working on other new tools to combat TB. “We’re working very closely with some excellent diagnostic manufacturers to make TB diagnostic tests, as well as with the Lilly TB Drug Discovery Initiative and the TB Drug Accelerator to identify and develop new TB drug targets,” Dr. Reed said.

Jamie Rosen is the media & communications manager for Aeras, a GHTC member. Aeras and the TuBerculosis Vaccine Initiative (TBVI) recently hosted a booth at the Union World Conference on Lung Health to hear from conference attendees about the need for a new TB vaccine. This blog post reflects what Aeras heard and experienced at the conference. “TB vaccines, urgently needed. For how long should we be patient!” Nigerian Egbagbe Eruke’s eloquent words were echoed through the halls of the Lille Grand Palais. Physicians, academicians, and members of civil society and the private sector from over 100 countries gathered in Lille, France from Oct. 26-30 to discuss challenges in controlling tuberculosis (TB) and other lung health issues at the 42nd World Conference on Lung Health, hosted by the International Union Against Tuberculosis and Lung Disease. Conference participants were not shy in their calls for new vaccines to fight the world’s second deadliest infectious disease. “In TB, we are stuck with a 90-year-old vaccine that has limited efficiency! We need to move on!” appealed Lucica Ditiu, executive secretary of the Stop TB Partnership. “It’s time to think that we are all in the same boat of humanity,” added patient advocate Alberto Colorado, who lives along the US/Mexico border. Dr. Milton Chemhuren of Zimbabwe had this to say: “Prevention is the best, so I support the introduction of new vaccines. We can save a lot of lives and resources. Today our health services systems are overwhelmed by TB patients, especially with the HIV which has fueled TB in our countries.” This resounding support was captured on a world map at the exhibit booth shared by Aeras and the TuBerculosis Vaccine Initiative (TBVI). By the end of the conference, the map was covered with demands for new vaccines against TB. A slideshow was made to showcase the other messages. Modeling studies have shown that without new tools to fight TB, including vaccines, we will not come close to meeting the international goal to eliminate TB by 2050. Fortunately, after decades of research neglect, the past 10 years have welcomed dramatic progress in TB vaccine development, with 12 vaccine candidates currently in clinical trials. While scientific challenges remain—for example, there is no shortcut that accurately predicts immunity by looking at animal models or immune responses when the vaccine is given to people—progress has been substantial. These challenges help to explain the long timelines of TB vaccine development. Researchers estimate that we could have a new TB vaccine by 2020, assuming there is sufficient financial support and at least one of the current candidates meets efficacy requirements. Developing new vaccines against TB requires giving candidate vaccines to thousands of people in areas where TB is highly endemic—and then waiting to see how many get sick with TB in the vaccine group versus the control group. Before beginning these large-scale efficacy trials, each vaccine candidate must also be evaluated for safety in smaller trials in multiple populations. Right now, the most advanced TB vaccines under development are in Phase IIb clinical trials, sponsored by Aeras. In addition to co-hosting an exhibit booth, Aeras co-organized two sessions at this year’s Union Conference, “Partnerships to Accelerate TB Vaccine Development” and “Synergies in the Development of New Diagnostics, Drugs and Vaccines for Tuberculosis.” Two of the presentations from the first session are currently available as webcasts online, one by Aeras’ Chief Scientific Officer Tom Evans on “New Tuberculosis Vaccines in Clinical Development” and one by Videlis Nduba, Primary Investigator at the Kenya Medical Research Institute/US Centers for Disease Control and Prevention (KEMRI/CDC), on “Ensuring Site Capacity for Large-Scale and Multicentre Vaccine Trials.” Perhaps the highlight of the conference for many of us involved in TB vaccine development was a reception at the Institut Pasteur de Lille co-hosted by Aeras, Institut Pasteur de Lille, TBVI and the Stop TB Partnership Working Group on New Vaccines. After the formal reception, attendees had the surprise opportunity to tour the museum at the Institut Pasteur de Lille, which in addition to chronicling the life and work of Louis Pasteur also details the work of Albert Calmette and Camille Guérin in co-discovering the BCG vaccine. To make BCG, Calmette and Guérin passed bovine TB bacteria over potatoes from 1908 to 1921 to weaken its infectious properties and then gave it to a newborn infant in Paris, in whom it was effective in protecting against TB disease. Of particular interest were some of the original potatoes that these bacteria were passed over, as well as a model of an experiment using BCG to protect cows against bovine TB. BCG was given to 11 cows, then 12 were exposed to bovine TB. The dead cow on the left is the “control group” for this experiment, the only cow who did not receive BCG. Sylvain Guérin, the great grandson of Camille Guérin, expressed his support for modern TB vaccine research. “Camille Guérin has devoted his life to this fight and has tried to contribute with the BCG, and I would like to continue in order to perpetuate the family tradition,” he wrote on the exhibit booth map. While BCG has not been effective in preventing adult pulmonary TB, the most common and infectious form of the disease, it remains the most widely used vaccine in the world and has saved the lives of countless children who may otherwise have developed severe forms of disseminated TB. But with advances in modern science, we know we can do better, and with repeated pleas from conference-goers and others, we know we must. Aeras and its partners will continue to heed these calls until the world has new TB vaccines that are safe and effective for people of all ages, including people living with HIV, and are affordable and available to all who need them throughout the world.